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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Development and U.S. Regulation of Preventive Vaccines

Enroll
Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Thu, 12/15/22: 12:00 AM EST
Ends On: Mon, 12/15/25: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: This webinar will provide an overview of the development and federal regulations for vaccines in the United States. We will discuss key statutes that grants the Food and Drug Administration authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval. The basic vaccine development process and key regulatory milestones will also be covered.
Objectives:
  • Identify the legislative Acts leading to and authorizing FDA to regulate preventive vaccines and discuss the historical context of each.
  • List basic regulatory requirements and types of data needed to support vaccine licensure and marketing approval.
  • Outline the usual vaccine development process from conception to marketing and explain key regulatory milestones during the process.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES